Approval of performance vs. Design input
`
`Quality plan review
`
`
`
`Edwards Liftscirncu
`
`E-Judn’: {thbciflk‘fl
`
`Manufacturing documentation readiness
`
`Next activities
`
`
`
`Edumics Lifesciences
`
`15-1». .u'cs 1in .«L Karma:
`
`Preclinical 8. Clinical studies
`
`Schedule
`
`Confifiei‘flci
`
`Eilwanu likx‘iirncu
`
`Edllifl} liflscil'ncr:
`
`Edwards Lifesciences v. Boston Scientific Scimed
`
`IPR2017-00060 U.S. Patent 8,992,608
`
`7 Exhiblt 2043 - Part 2
`h
`PROTECTIVE ORDER MATERIAL
`
`Highly Confidential
`
`Page 21 0f 43
`EDWARDS 01033864
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`
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`Quality plan review
`
`
`
`Edwards Liftscirncu
`
`E-Judn’: {thbciflk‘fl
`
`Manufacturing documentation readiness
`
`Next activities
`
`
`
`Edumics Lifesciences
`
`15-1». .u'cs 1in .«L Karma:
`
`Preclinical 8. Clinical studies
`
`Schedule
`
`Confifiei‘flci
`
`Eilwanu likx‘iirncu
`
`Edllifl} liflscil'ncr:
`
`Edwards Lifesciences v. Boston Scientific Scimed
`
`IPR2017-00060 U.S. Patent 8,992,608
`
`7 Exhiblt 2043 - Part 2
`h
`PROTECTIVE ORDER MATERIAL
`
`Highly Confidential
`
`Page 21 0f 43
`EDWARDS 01033864
`
`
`
`
`
`Elll'nllisl ibi-(mu‘fi
`
`Closing Slide
`
`
`
`
`
`
`Helong panents is our ife's work. and
`
`90 We”)
`
`ELI-m Lifthmccs
`
`
`
`Edwards Lifesciences v. Boston Scientific Scimed
`
`5
`
`IPR2017-00060 U.S. Patent 8,992,608
`
`Higi’iiy Confidential
`
`PROTECTIVE ORDER MATERIAL
`
`EDWARDS 01033865
`
`
`
`Edwards
`
`PVL - Paravaivuiar leak prevention
`Preiiminary design review
`:Ian Haia':
`luv )6 )5
`
`The Project’s Mission:
`
`l,ll‘%‘\fll$1.|lrf512l‘.l11ti
`
`Preliminary spec ‘
`
`Project objectives:
`
`M
`
`'
`
`l
`
`Seiutioh cofiCeptz
`
`
`
`EdwnbLIlcnu'mc:
`
`_ Eleliminary spec:
`
`'
`
`..
`
`l
`
`Edwards Lifesciences v. Boston Scientific Scimed
`
`lPR2017-00060 U.S. Patent 8,992,608
`Exhibit 2043 - Part 2
`
`Highly Confidential
`
`PROTECTIVE ORDER MATERIAL
`
`1
`
`Page 23 of 43
`EDWARDS 01033866
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`
`
`Preliminary spec:
`
`Preliminary spec:
`
`Eduard: I .ifirx‘lr nuts
`
`Risk evaluation
`
`Feasibility tests:
`
`
`
`Edward: I.i[r-«nr-nrr:.
`
`Prototvnes and tests results:
`
`Md: Ux‘nitucu
`
`Edwards Lifesciences v. Boston Scientific Scimed
`
`IPR2017-00060 U.S. Patent 8,992,608
`
`2
`
`Highly Conficential
`
`PROTECTIVE ORDER MATERIAL
`
`EDWARDS 01033867
`
`
`
`Prototypes and tests results:
`
`Prototypes and tests results:
`
`Ed“ ml: Lilcssiun'L-s
`
`Prototypes and tests results:
`
`Prototypes and tests results:
`
`Delivery System modifications
`
`lid». uds blessiwcc:
`
`Prototypes and tests results:
`
`Edwards Lifesciences v. Boston Scientific Scimed
`
`IPR2017-00060 U.S. Patent 8,992,608
`
`3
`
`Highly Conficential
`
`PROTECTIVE ORDER MATERIAL
`
`EDWARDS 01033868
`
`
`
`Work plane (short term)
`
`Work plane (short term)
`
`
`
`iiiwunt Lil} 5C.Cr.CC\
`
`7
`
`Edwards Lila-irate;
`
`
`
`Animal Study (feasibility)
`
`Quality & Regulatory plans
`
`Edward: Liiucivmc:
`
`.
`
`Edwards Liftscirmrcs I
`
`Input checklist vs output checklist
`
`Edwards Hirsuirni rs
`
`Edwards Lifesciences v. Boston Scientific Scimed
`
`IPR2017-00060 U.S. Patent 8,992,608
`
`4
`
`Highly Confidential
`
`PROTECTIVE ORDER MATERIAL
`
`EDWARDS 01033869
`
`
`
`
`
`‘
`
`Schedule
`
`Edwin]: Ufraciruc:
`
`[dram]: Liinticmcs
`
`
`
`
`
`Closing Slide
`
`
`
`
`
`Edward;
`Heloing paiients is our life‘s work, and
`. W
`WW
`
`i’kluurtl; Lifrw irrco:
`
`Edwards Lifesciences v. Boston Scientific Scimed
`
`_ #
`Highly Confidential
`
`lPR2017-00060 U.S. Patent 8,992,608
`Exhibit 2043 - Part 2
`PROTECTIVE ORDER MATERIAL
`
`5
`Page 27 of 43
`EDWARDS 01033870
`
`
`
`
`
`Next Generation PHV
`
`PHV2
`
`PHV2
`
`System Requirements
`
`Design Review
`
`Senamli Spenser
`m 2025
`
`Elillilmihirl.i|'i-uir:i.r-
`
`‘
`
`i
`
`‘1 ”I “1 M ‘L'
`
`'n
`2:3 i'.d\ui.‘-i- Lifm ii‘il 'r~
`
`Summery of assumption -
`Marketing needs design inputs
`
`
`
`
`
`
`
`: Egg.liilmel_ifi;,iic:|-i~.
`
`"
`
`’
`
`«_
`
`‘
`
`J'
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`" Eig-iuiwuhi-l,if.-~<':r:i1‘-
`
`More assumptions
`
`Old and New questions:
`
`’
`-“ .
`‘ gfli'i!“ll'llwl‘ih'w'iflii'i‘:
`
`Highly Confidential
`
`PROTECTIVE ORDER MATERIAL
`
`Page 28 of 43
`EDWARDS 01033871
`
`Edwards Lifesciences v. Boston Scientific Scimed
`
`IPR2017-00060 U.S. Patent 8,992,608
`Exhibit 2043 - Part 2
`
`
`
`Points settled
`
`Concept presentation:
`The PHV2 stent
`
`5‘ ti;1 il'u'mlll\ Lliv-ir l u»
`
`
`
`Concept presentation:
`
`resent t'
`
`3
`
`resentation:
`
`Preliminary AWT
`
`on new desions
`
`Edwards Lifesciences v. Boston Scientific Scimed
`
`l‘J
`
`IPR2017-00060 U.S. Patent 8,992,608
`
`
`Highly Confidential
`
`PROTECTIVE ORDER MATERIAL
`
`EDWARDS 01033872
`
`
`
`resentation:
`
`Current activities
`
`E325, rim-m Lift-ain't?- " it}? i,(l'.\‘:l'4i~1.1f- uirnu‘:
`
`
`
`Preliminary Regulatory plan
`
`‘
`
`
`
`Preliminar Re
`
`
`
`
`
`H E i JmcrtL i Iii-m ll'l‘l’l"
`
`Preliminary clinical Plan
`
`Preliminary development plan
`
`.. Elli-Mum1mm.
`
`" Hummi-i..ri-..l..-nl..
`
`x
`
`'
`
`' "
`
`‘
`
`‘
`
`
`
`lPR2017-00060 U.S. Patent 8,992,608
`
`Edwards Lifesciences v. Boston Scientific Scimed
`
`II)
`
`Highly Confidential
`
`‘
`
`‘
`
`'
`
`PROTECTIVE ORDER MATERIAL
`
`EDWARDS 01033373
`
`
`
`Schedule
`
`To be presented in PDR.
`
`Me
`
`.-.
`
`demls LifL'Mll'lll't:
`
`He :‘nj pm err; IS ”.1! He‘s wan. and
`
`['leird: Liil'wivnrn
`
`Highly Confidential
`
`Edwards Lifesciences v. Boston Scientific Scimed
`
`IPR2017-00060 U.S. Patent 8,992,608
`Exhibit 2043 - Part 2
`PROTECTIVE ORDER MATERIAL
`
`Page 31 of 43
`EDWARDS 01033874
`
`
`
`
`
` Edwards
`
`
`
`Critical Design Review
`Emumn Spun":
`1S Ju'v zoos
`
`lad-Maids l.:[urir:.;'r-
`
`The sucgested design (Take — ‘i
`
` [uh-Lumlle-y. min-r»1
`
`
`
`;
`
`
`
`Technical mqulremcnts
`
`Highly Conficential
`
`Edwards Lifesciences v. Boston Scientific Scimed
`
`IPR2017-00060 U.S. Patent 8,992,608
`Exhibit 2043 - Part 2
`PROTECTIVE ORDER MATERIAL
`
`Page 32 of 43
`EDWARDS 01033875
`
`
`
`1
`
`Mtg-in] AILN‘iK'lt‘fi-
`
`[IIWAIILIALJHIR me":
`
`In Vitro Test Plan
`
`Customers‘ feedback
`
`
`
`
`
`Sterilization
`
`
`
`
`n..- 1..-,
`Ethan]: [Ah-smut“?
`
`
`
`ces v. Boston Scientific Scimed
`
`060 U.S. Patent 8,992,608
`
`Ix)
`
`Highly Conficential
`
`PROTECTIVE ORDER MATERIAL
`
`EDWARDS 01033876
`
`
`
`Documentation
`
`1 1min” l.n'r:nr:1..~~«y
`“a: dAI-v‘v
`
`Ift lwarils
`
`Design Input vs. Output
`Hun'r» |J.’I:.~r.u.t.»a %
`
`‘05. wow, and
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`l"l‘J-llfllxl,lf’l'4 rnw‘-.
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`.-.......... awn—w...“
`1i
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`l
`
`Hesmg static-ms :3 fiu!‘
`
`. W6")
`
`Cost calculation
`
`
`
`Edwards Lifesciences v. Boston Scientific Scimed
`
`(,1
`
`IPR2017-00060 U.S. Patent 8,992,608
`
`Highly Confidential
`
`PROTECTIVE ORDER MATERIAL
`
`EDWARDS 01033877
`
`
`
`Background
`
`grimslime
`i as
`$153me
`ltdwa l‘ilS
`
`.lremnmary UBSIg/l REVIEW
`
`As s’ul 8:45P:
`. J!) 2205
`
`Objectives
`
`Technical requirements
`
`
`
`Unaub Ulr-u {runes
`
`[Eh-nus “Ivy mun
`
`
`
`Technical requirements
`
`Early models
`
`Luv-um utuucni'cs
`
`Edwards Lifesciences v. Boston Scientific Scimed
`
`IPR2017-00060 U.S. Patent 8,992,608
`Exhibit 2043 - Part 2
`
`Highly Confidential
`
`PROTECTIVE-ORDER MATERIAL
`
`Page 35 of 43
`EDWARDS 01033878
`
`
`
`Customers’ feedback
`
`Customers’ feedback
`
`Eduard: Lifesci- nets
`
`4‘" model
`
`Option 1
`
`Hunts lJIuirncr:
`
`Ehunfs Lifucmrxc:
`
`‘ O
`
`
`
`
`ption 3
`
`linlvumm 1Jr(36ifi.l'l‘!
`
`Edwards Lifesciences v. Boston Scientific Scimed
`IPR2017-00060 U.S. Patent 8,992,608
`
`2
`
`Highly Confidential
`
`PROTECTIVE ORDER MATERIAL
`
`EDWARDS 01033879
`
`
`
`Option 4
`
`Regulatory 8. Clinical path
`
`Enimnlsljincirnm-
`
`E-luni: Liim'iuu':
`
`What next
`
`Schedule 8 Budget
`
`
`
`Edwani: Liftscii-ncu
`
`lzdwm‘ds
`
`Holohg paizoris is our Mes work am:
`
`.w
`
`Edn nl ii : Eli's-dc m I:
`
`Edwards Lifesciences v. Boston Scientific Scimed
`IPR2017-00060 U.S. Patent 8,992,608
`
`3
`
`Highly Confidential
`
`PROTECTIVE ORDER MATERIAL
`
`EDWARDS 01033880
`
`
`
`
`
`Edwards Lifesciences v. Boston Scientific Scimed
`
`IPR2017-00060 U.S. Patent 8,992,608
`
`Highly Confidential
`
`PROTECTIVE ORDER MATERIAL
`
`EDWARDS 01033881
`
`
`
`
`
`
`
`Edwards Lifesciences v. Boston Scientific Scimed
`
`IPR2017-00060 U.S. Patent 8,992,608
`
`Highly Confidential
`
`PROTECTIVE ORDER MATERIAL
`
`EDWARDS 01033882
`
`
`
`
`
`Edwards Lifesciences v. Boston Scientific Scimed
`
`.Q§_~ifli ,
`
`Highly Confidential
`
`PROTECTIVE ORDER MATERIAL
`
`EDWARDS 01033883
`
`IPR2017-00060 U.S. Patent 8,992,608
`
`
`
`
`
`Edwards Lifesciences v. Boston Scientific Scimed
`
`IPR2017-00060 U.S. Patent 8,992,608
`
`Highly Confidential
`
`PROTECTIVE ORDER MATERIAL
`
`EDWARDS 01033884
`
`
`
`
`
`
`
`
`Edwards Lifesciences v. Boston Scientific Scimed
`
`IPR2017-00060 U.S. Patent 8,992,608
`
`
`.1...
`
`Highly Confidential
`
`PROTECTIVE ORDER MKT’ERI’AL
`
`EDWARDS 01033885
`
`
`
`
`
`IPR2017-00060 U.S. Patent 8,992,608
`
`
`Edwards Lifesciences v. Boston Scientific Scimed
`
`Highly Confidential
`
`Exhibit 2043 - Part 2
`PROTECTIVE ORDER MATERIAL
`
`:>
`
`"‘
`
`Page 43 of 43
`EDWARDS 01033886
`
`
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